Trial Outcomes & Findings for Speech Locator In-car Performance Evaluation (NCT NCT05054816)
NCT ID: NCT05054816
Last Updated: 2025-08-17
Results Overview
The sound quality ratings will be conducted via a computer-based questionnaire that contains sound samples that participants listen to and rate. Sound quality rating scales are continuous and range from 0 (worst) to 100 (best) with 5 descriptors unique to the dimension at 5 intervals on the scale (0, 25, 50, 75, 100) Participants will be instructed to "Please rate the clarity of speech". Speech clarity ratings will be measured on a 100-point continuous slider from worst to best (0-Very unclear, 25- Unclear, 50-Slightly clear, 75-Clear, 100-Very clear). Speech clarity ratings are expected to be impacted by how intelligible the speech is. Participants will rate and compare speech clarity between the investigational and comparator features.
COMPLETED
NA
20 participants
Up to 6 hours over 3 2-hour sessions
2025-08-17
Participant Flow
Participant milestones
| Measure |
Participants With Hearing Loss
Participants with hearing loss who are candidates for hearing aids
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Speech Locator In-car Performance Evaluation
Baseline characteristics by cohort
| Measure |
Participants With Hearing Loss.
n=20 Participants
Participants with hearing loss.
Investigational adaptive directional microphone strategy: A receiver-in-canal hearing aid developed by the Study Sponsor used with the investigational adaptive directional microphone strategy that is expected to improve sound quality of speech in a car.
Comparator omnidirectional microphone strategy: A receiver-in-canal hearing aid developed by the Study Sponsor used with the comparator omnidirectional microphone strategy that is used with the default settings as specified in the manufacturer's fitting software.
Comparator fixed directional microphone strategy: A receiver-in-canal hearing aid developed by the Study Sponsor used with the comparator fixed directional microphone strategy that is used with the default settings as specified in the manufacturer's fitting software.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
|
Age, Continuous
|
68 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
20 Participants
n=5 Participants
|
|
Hearing loss severity
Mild
|
15 Participants
n=5 Participants
|
|
Hearing loss severity
Moderate
|
3 Participants
n=5 Participants
|
|
Hearing loss severity
Moderate-Severe
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 6 hours over 3 2-hour sessionsPopulation: Two participants' data were omitted due to their results suggesting that they did not understand the task.
The sound quality ratings will be conducted via a computer-based questionnaire that contains sound samples that participants listen to and rate. Sound quality rating scales are continuous and range from 0 (worst) to 100 (best) with 5 descriptors unique to the dimension at 5 intervals on the scale (0, 25, 50, 75, 100) Participants will be instructed to "Please rate the clarity of speech". Speech clarity ratings will be measured on a 100-point continuous slider from worst to best (0-Very unclear, 25- Unclear, 50-Slightly clear, 75-Clear, 100-Very clear). Speech clarity ratings are expected to be impacted by how intelligible the speech is. Participants will rate and compare speech clarity between the investigational and comparator features.
Outcome measures
| Measure |
Participants With Hearing Loss.
n=18 Participants
Participants with hearing loss.
Investigational adaptive directional microphone strategy: A receiver-in-canal hearing aid developed by the Study Sponsor used with the investigational adaptive directional microphone strategy that is expected to improve sound quality of speech in a car.
Comparator omnidirectional microphone strategy: A receiver-in-canal hearing aid developed by the Study Sponsor used with the comparator omnidirectional microphone strategy that is used with the default settings as specified in the manufacturer's fitting software.
Comparator fixed directional microphone strategy: A receiver-in-canal hearing aid developed by the Study Sponsor used with the comparator fixed directional microphone strategy that is used with the default settings as specified in the manufacturer's fitting software.
|
|---|---|
|
Speech Clarity
Investigational adaptive directional microphone strategy
|
77.2 units on a scale
Standard Error 3.7
|
|
Speech Clarity
Comparator omnidirectional microphone strategy
|
76.6 units on a scale
Standard Error 3.7
|
|
Speech Clarity
Comparator fixed directional microphone strategy
|
63.6 units on a scale
Standard Error 3.7
|
PRIMARY outcome
Timeframe: Up to 6 hours over 3 2-hour sessionsPopulation: Two participants' data were omitted due to their results suggesting that they did not understand the task.
The sound quality ratings will be conducted via a computer-based questionnaire that contains sound samples that participants listen to and rate. Sound quality rating scales are continuous and range from 0 (worst) to 100 (best) with 5 descriptors unique to the dimension at 5 intervals on the scale (0, 25, 50, 75, 100) Participants will be instructed to "Please rate how annoying the noise is". Noise annoyance ratings will be measured on a 100-point continuous slider from worst to best (0- Extremely annoying, 25-Very annoying, 50-Moderately annoying, 75-Slightly annoying, 100-Not at all annoying). Noise annoyance ratings are expected to be impacted by how bothersome the background noise in the recordings is. Participants will rate and compare noise annoyance between the investigational and comparator features.
Outcome measures
| Measure |
Participants With Hearing Loss.
n=18 Participants
Participants with hearing loss.
Investigational adaptive directional microphone strategy: A receiver-in-canal hearing aid developed by the Study Sponsor used with the investigational adaptive directional microphone strategy that is expected to improve sound quality of speech in a car.
Comparator omnidirectional microphone strategy: A receiver-in-canal hearing aid developed by the Study Sponsor used with the comparator omnidirectional microphone strategy that is used with the default settings as specified in the manufacturer's fitting software.
Comparator fixed directional microphone strategy: A receiver-in-canal hearing aid developed by the Study Sponsor used with the comparator fixed directional microphone strategy that is used with the default settings as specified in the manufacturer's fitting software.
|
|---|---|
|
Noise Annoyance
Investigational adaptive directional microphone strategy
|
71.1 units on a scale
Standard Error 3.25
|
|
Noise Annoyance
Comparator omnidirectional microphone strategy
|
61.4 units on a scale
Standard Error 3.25
|
|
Noise Annoyance
Comparator fixed directional microphone strategy
|
60.0 units on a scale
Standard Error 3.25
|
PRIMARY outcome
Timeframe: Up to 6 hours over 3 2-hour sessionsPopulation: Two participants' data were omitted due to their results suggesting that they did not understand the task.
The sound quality ratings will be conducted via a computer-based questionnaire that contains sound samples that participants listen to and rate. Sound quality rating scales are continuous and range from 0 (worst) to 100 (best) with 5 descriptors unique to the dimension at 5 intervals on the scale (0, 25, 50, 75, 100) Participants will be instructed to "Please rate your confidence that the talker is in \[a location\]", with the local being either passenger of rear left. Spatialization ratings will be measured on a 100-point continuous slider from worst to best (0-I don't know where the talker is, 25-The talker might be to my \[location\], 50-The talker is probably to my \[location\], 75-The talker is to my \[location\], 100-The talker is definitely to my \[location\]). Spatialization ratings are expected to be impacted by how well the recordings preserve spatial perception. Participants will rate and compare spatialization between the investigational and comparator features.
Outcome measures
| Measure |
Participants With Hearing Loss.
n=18 Participants
Participants with hearing loss.
Investigational adaptive directional microphone strategy: A receiver-in-canal hearing aid developed by the Study Sponsor used with the investigational adaptive directional microphone strategy that is expected to improve sound quality of speech in a car.
Comparator omnidirectional microphone strategy: A receiver-in-canal hearing aid developed by the Study Sponsor used with the comparator omnidirectional microphone strategy that is used with the default settings as specified in the manufacturer's fitting software.
Comparator fixed directional microphone strategy: A receiver-in-canal hearing aid developed by the Study Sponsor used with the comparator fixed directional microphone strategy that is used with the default settings as specified in the manufacturer's fitting software.
|
|---|---|
|
Spatialization
Investigational adaptive directional microphone strategy
|
78.2 units on a scale
Standard Error 6.42
|
|
Spatialization
Comparator omnidirectional microphone strategy
|
77.7 units on a scale
Standard Error 6.42
|
|
Spatialization
Comparator fixed directional microphone strategy
|
50.5 units on a scale
Standard Error 6.42
|
PRIMARY outcome
Timeframe: Up to 6 hours over 3 2-hour sessionsPopulation: Two participants' data were omitted due to their results suggesting that they did not understand the task. The "fixed directional" outcome measure is not included for the transition annoyance comparator since that program does not contain transitions that can be rated and compared to the other test conditions.
The sound quality ratings will be conducted via a computer-based questionnaire that contains sound samples that participants listen to and rate. Sound quality rating scales are continuous and range from 0 (worst) to 100 (best) with 5 descriptors unique to the dimension at 5 intervals on the scale (0, 25, 50, 75, 100) Participants will be instructed to "Please rate how annoying the transitions are". Transitions annoyance ratings will be measured on a 100-point continuous slider from worst to best (0-Extremely annoying, 25-Very annoying, 50-Moderately annoying, 75-Slightly annoying, 100-Not at all annoying). Transition annoyance ratings are expected to be influenced by presence of unexpected sounds or transitions that occur in different microphone modes and different listening situations. Participants will rate and compare transition annoyance between the investigational and comparator features.
Outcome measures
| Measure |
Participants With Hearing Loss.
n=18 Participants
Participants with hearing loss.
Investigational adaptive directional microphone strategy: A receiver-in-canal hearing aid developed by the Study Sponsor used with the investigational adaptive directional microphone strategy that is expected to improve sound quality of speech in a car.
Comparator omnidirectional microphone strategy: A receiver-in-canal hearing aid developed by the Study Sponsor used with the comparator omnidirectional microphone strategy that is used with the default settings as specified in the manufacturer's fitting software.
Comparator fixed directional microphone strategy: A receiver-in-canal hearing aid developed by the Study Sponsor used with the comparator fixed directional microphone strategy that is used with the default settings as specified in the manufacturer's fitting software.
|
|---|---|
|
Transition Annoyance
Investigational adaptive directional microphone strategy
|
71.7 units on a scale
Standard Error 3.89
|
|
Transition Annoyance
Comparator omnidirectional microphone strategy
|
74.1 units on a scale
Standard Error 3.89
|
PRIMARY outcome
Timeframe: Up to 6 hours over 3 2-hour sessionsPopulation: Two participants' data were omitted due to their results suggesting that they did not understand the task.
The sound quality ratings will be conducted via a computer-based questionnaire that contains sound samples that participants listen to and rate. Sound quality rating scales are continuous and range from 0 (worst) to 100 (best) with 5 descriptors unique to the dimension at 5 intervals on the scale (0, 25, 50, 75, 100) Participants will be instructed to "All things considered, please rate overall preferences". Overall preferences ratings will be measured on a 100-point continuous slider from worst to best (0-Bad, 25-Poor, 50-Fair, 75-Good, 100-Excellent). Overall impression ratings are expected to be impacted by participants' overall preferences for the different stimuli. Participants will rate and compare overall impression between the investigational and comparator features.
Outcome measures
| Measure |
Participants With Hearing Loss.
n=18 Participants
Participants with hearing loss.
Investigational adaptive directional microphone strategy: A receiver-in-canal hearing aid developed by the Study Sponsor used with the investigational adaptive directional microphone strategy that is expected to improve sound quality of speech in a car.
Comparator omnidirectional microphone strategy: A receiver-in-canal hearing aid developed by the Study Sponsor used with the comparator omnidirectional microphone strategy that is used with the default settings as specified in the manufacturer's fitting software.
Comparator fixed directional microphone strategy: A receiver-in-canal hearing aid developed by the Study Sponsor used with the comparator fixed directional microphone strategy that is used with the default settings as specified in the manufacturer's fitting software.
|
|---|---|
|
Overall Impression
Investigational adaptive directional microphone strategy
|
61 units on a scale
Standard Error 2.8
|
|
Overall Impression
Comparator omnidirectional microphone strategy
|
58.7 units on a scale
Standard Error 2.8
|
|
Overall Impression
Comparator fixed directional microphone strategy
|
40.6 units on a scale
Standard Error 2.8
|
Adverse Events
Participants With Hearing Loss.
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jinyu Qian, PhD; VP Sonova Innovation Centre Toronto
Sonova Canada
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place